MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MBT REV TIB 2 DEG BROACH 61MM; KNEE INSTRUMENT : BROACHES

Catalog Number	217863117
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: examination of the returned device found assembly with the mating instrument not possible.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Event or Problem Description
It was reported that during revision tka the hudson adaptor continued to fail under torque.Also the 61 tibial sleeve broach would not accept the pilot.Both items are worn and need replacement.

• Brand Name: MBT REV TIB 2 DEG BROACH 61MM
• Common Device Name: KNEE INSTRUMENT : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8724168
• Report Number: 1818910-2019-96521
• Device Sequence Number: 1685641
• Product Code: HTQ
• UDI-Device Identifier: 10603295096146
• UDI-Public: 10603295096146
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 217863117
• Device Lot Number: A1204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 75